Dry Needling Versus Instrumented Assisted Soft Tissue Mobilization In the Patient With Cervicogenic Treatment Headache (DN)

Dry Needling Versus Instrumented Assisted Soft Tissue Mobilization In the Patient With Cervicogenic Treatment Headache; Randomized Controlled Trial

the aim of this study is to investigate the efficacy of Dry Needling Versus Instrumented Assisted Soft Tissue Mobilization In the Patient With Cervicogenic Treatment Headache

Study Overview

• Status: Not yet recruiting
• Conditions: Cervicogenic Headache
• Intervention / Treatment: Other: dry needling; Other: conventional therapy; Other: instrumented assisted soft tissue mobilization

Detailed Description

Cervicogenic headache has been classified as a secondary type headache, and it is usually associated with cervical myofascial pain sources as myofascial trigger points . It also could be related to any joint, disc, and ligament disease of the upper region of the neck.physiotherapist use trigger point dry needling as an invasive treatment for CGH where a solid filament needle is inserted into a myofascial trigger point . The advantages of Dry needling are increasingly documented .Instrument-assisted soft tissue mobilization technique has been reported to decrease pain, improve overall function, and increase range of motion . It enhances the ability of physical therapists to detect altered tissue properties, through the vibration sense within the instrument, and to treat soft tissue dysfunction. It also enhances the patient's awareness of altered sensations within the treated tissues.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 20 to 60 years old patient with unilaterally of the head pain
• pain triggered by external pressure over the upper cervical joints (c1-c3)
• pain elicited by the neck movements, and/or sustained awkward positions with reduced neck ROM
• headache intensity pain score of at least 20mm on the Visual analogue scale (VAS)
• headache frequency of at least once a week for at least 3 months
• minimum neck disability index score of 10 points or greater

Exclusion Criteria:

• Migraine, tension- type headache, tumor, osteoporosis, fracture, rheumatoid arthritis and metabolic diseases.
• Prolonged history of steroid use.
• Resting blood pressure greater than 140/90 mmhg.
• cervical spinal stenosis, diminished sensation and central nervous system involvement,
• previous head or neck surgery or whiplash injury history within the last 6 weeks

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: dry needling; the patient will receive dry needling and conventional therapy three times per week for four weeks	Other: dry needling; the patient will be in comfortable position .and clean the area over upper trapezius and sub occipital muscles. detect the trigger point then Perpendicular needling into the bulk of the muscle is the safest technique for this area.; Other: conventional therapy; patients will be received traditional physiotherapy (stretching and strengthening cervical muscles and postural correction exercise)
Experimental: instrumented assisted soft tissue mobilization; the patient will receive instrumented assisted soft tissue mobilization and conventional therapy three times per week for four weeks	Other: conventional therapy; patients will be received traditional physiotherapy (stretching and strengthening cervical muscles and postural correction exercise); Other: instrumented assisted soft tissue mobilization; the patients will be in sitting position. The appropriate IASTM technique instrument will be selected to scan, and then treat the affected area for 30 to 60 seconds per treated area. The procedure will be applied to the superficial cervical fascia and investing the layers of deep cervical fascia that surround all the structures in the neck. Strokes will be applied on the sub occipital and upper fibers of trapezius muscle. The IASTM technique will be applied at a 45° angle in a direction parallel to the treated muscle fibers for 20 seconds, followed immediately by an additional 20 seconds application at a 45° angle in a perpendicular direction to the muscle fibers, resulting in a total treatment time of approximately 40 seconds. The patients will be advised that they might be sore, bruised, or have small red dots called petechiae, on the treated area. Ice will be applied for 15 to 20 min after the treatment if there will be a massive soreness.
Active Comparator: conventional therapy; the patient will receive conventional therapy three times per week for four weeks	Other: conventional therapy; patients will be received traditional physiotherapy (stretching and strengthening cervical muscles and postural correction exercise)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
pain intensity	visual analogue scale will be used to asses pain intensity which patient will be instructed to put point on line from no pain to tolerable pain. The scale consists of a line, usually 10 cm long, ranging from no pain or discomfort (zero) , to the worst pain that could possibly feel .	up to four weeks
neck disability	will be measured by Arabic neck disability index. It contains ten category/classes. Each category contains six choices (zero-five).Score from zero to four no disability, from five to 15 this is mild, From 15 to 24 this is moderate, from 25 to 34 this is severe, more than 34 this is a complete disability	up to four weeks
pressure pain threshold	pressure pain threshold will be assessed by commander algometer	up to four weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
range of motion	range of motion will be measured by inclinometer CROM. The CROM (deluxe version - Performance Attainment Associates, Roseville, MN, USA) measures the cervical range of motion5- for flexion, extension, lateral flexion, and rotation using separate inclinometers. These inclinometers are attached to a frame similar to that for eyeglasses one in the sagittal plane for flexion - extension, second in the frontal plane for lateral flexion and a third in the horizontal plane for rotation.	up to four weeks
headache frequency	the number of days the subjects feel headache (headache frequency).	up to four weeks
medication intake	from the patients' diary in the last week , medications intake will be recorded as follow: 1) not at all; 2) once a week; 3) once every couple of days; 4) once or twice a day; or 5) three or more times a day	up to four weeks
headache duration	the total hours of headache (headache duration).	up to four weeks

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Anticipated): July 5, 2022
• Primary Completion (Anticipated): October 30, 2022
• Study Completion (Anticipated): October 30, 2022

Study Registration Dates

• First Submitted: June 26, 2022
• First Submitted That Met QC Criteria: July 2, 2022
• First Posted (Actual): July 7, 2022

Study Record Updates

• Last Update Posted (Actual): July 7, 2022
• Last Update Submitted That Met QC Criteria: July 2, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: dry needling; cervicogenic headache; instrumented assisted soft tissue mobilization
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Headache Disorders; Headache Disorders, Secondary; Headache; Post-Traumatic Headache
• Other Study ID Numbers: p.t.rec/012/003725

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No